(134 days)
The Intravascular Administration Set is a single use, sterile device that provides access for the administration of fluids from a container to the patients vascular system through the administration set's needle or catheter, which is inserted into a vein.
The 3 in 1 IV Administration Set is a single use, sterile, device sterilized with Ethylene Oxide gas. The 3 in 1 set is used to administer fluids from an IV container or syringe to a patient's vascular system through a needle or catheter. A choice can be easily made between 10, 15, or 60, drops/cc volume without breaking the line. This feature allows the healthcare provider the flexibility to treat the patient condition by turning the selector. The device may include a flow regulator, a drip chamber, backflow valve, fluid delivery tubing, connectors between parts of the set, needleless injection site, Y port, extension set, and a hollow spike to penetrate and connect the tubing to an IV bag or other infusion fluid container. VitalCare Group Inc. will offer standard sets and custom sets to meet customer requirements and specifications.
The provided text describes a medical device, the "3 In 1" I.V. Administration Set, and its 510(k) summary for clearance. However, it does not detail a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/ML device would.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K925465). This is a different type of validation process.
Here's an analysis based on the information provided, addressing your requested points where applicable, and noting where the information is not present for this type of medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (an IV administration set), the "acceptance criteria" are generally tied to demonstrating that the device performs as intended and is as safe and effective as a legally marketed predicate device. The performance data presented are primarily engineering bench tests to ensure the physical integrity and functionality of the set.
| Acceptance Criteria Category (Implied by Submission) | Reported Device Performance (from text) |
|---|---|
| Intended Use Equivalence | Identical to predicate device (K925465) |
| Component Similarity | Similar components and materials to predicate device |
| Biocompatibility | Performed (implies met relevant standards, though specific results not detailed) |
| Bench Testing - Physical Integrity | Pull testing, pressure testing, joint strength testing, and drop testing performed (implies met internal specifications, though exact criteria/results not detailed) |
| Sterilization/Residuals | Performed (Sterile via EO, implies met standards, though specifics not detailed) |
| Labeling Similarity | Similar to predicate device |
| Packaging Similarity | Similar to predicate device |
| Sterilization Method | Identical to predicate device (Sterile via EO) |
| Materials Used | Materials are used in legally marketed devices under comparable conditions (implies generally accepted and safe) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. For bench testing of physical properties, specific sample sizes are typically used for each test (e.g., n=30 for tensile strength). This information is not provided in the 510(k) summary.
- Data Provenance: The tests were performed internally by VitalCare Group, Inc., or by a contracted lab. The country of origin of the data is implicitly the USA (where the company is based and the submission was made). The testing is prospective in the sense that it was conducted specifically for this 510(k) submission to demonstrate device performance and safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a device like an IV administration set, "ground truth" as it relates to expert consensus in image analysis or clinical diagnosis is not relevant. The "ground truth" for performance is established by engineering specifications, material standards, and industry best practices. The "experts" would be the engineers and quality control personnel designing and testing the device, but their specific numbers and qualifications are not detailed in this summary.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists, pathologists) when establishing ground truth for diagnostic or AI performance studies. This is not a human-in-the-loop or diagnostic device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This type of study is for evaluating human performance, often with and without AI assistance, typically in diagnostic or screening contexts. It is not relevant for an IV administration set.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This device does not have an "algorithm" or AI component. It is a physical medical device.
7. The type of ground truth used
The "ground truth" for this device's performance is based on engineering specifications, material standards, and functional requirements for IV administration sets. This would include:
- Physical specifications (e.g., dimensions, flow rates)
- Material properties (e.g., tensile strength, chemical compatibility)
- Biocompatibility standards (e.g., ISO 10993)
- Sterility assurance (e.g., ISO 11135 for EO sterilization)
- Leakage and connection integrity standards.
The 510(k) summary indicates that "Pull testing, pressure testing, joint strength testing, and drop testing has been performed," which are standard engineering tests to verify these aspects.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, so there is no training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.